Table 3 The signal strength of AEs related to rotigotine at the SOC level in the FAERS database was detected by four algorithms
From: Rotigotine safety in real-world settings: a pharmacovigilance study using FAERS data
System organ class (SOC) | Case reports | ROR (95% CI) | PRR (χ²) | EBGM (EBGM05) | BCPNN (IC025) |
|---|---|---|---|---|---|
General Disorders And Administration Site Conditions* | 4803 | 1.28 (1.24–1.32) | 1.22 (231.24) | 1.22 (1.19) | 0.29 (-1.38) |
Nervous System Disorders* | 3407 | 1.94 (1.87–2.01) | 1.79 (1307.26) | 1.79 (1.74) | 0.84 (-0.82) |
Injury, Poisoning And Procedural Complications* | 2557 | 1.24 (1.19–1.29) | 1.21 (104.25) | 1.21 (1.17) | 0.28 (-1.39) |
Psychiatric Disorders* | 2302 | 1.89 (1.81–1.97) | 1.8 (865.62) | 1.8 (1.73) | 0.85 (-0.82) |
Product Issues* | 2058 | 6.22 (5.94–6.51) | 5.74 (8166.52) | 5.73 (5.51) | 2.52 (0.85) |
Gastrointestinal Disorders | 1082 | 0.54 (0.51–0.57) | 0.56 (401.82) | 0.56 (0.53) | -0.83 (-2.49) |
Skin And Subcutaneous Tissue Disorders | 942 | 0.77 (0.72–0.82) | 0.78 (64.64) | 0.78 (0.73) | -0.37 (-2.03) |
Musculoskeletal And Connective Tissue Disorders | 752 | 0.62 (0.57–0.66) | 0.63 (173.68) | 0.63 (0.59) | -0.67 (-2.33) |
Infections And Infestations | 630 | 0.52 (0.48–0.56) | 0.53 (277.11) | 0.53 (0.5) | -0.92 (-2.58) |
Cardiac Disorders | 547 | 0.94 (0.86–1.02) | 0.94 (2.28) | 0.94 (0.87) | -0.09 (-1.76) |
Surgical And Medical Procedures* | 525 | 1.74 (1.6–1.9) | 1.73 (162.87) | 1.73 (1.61) | 0.79 (-0.88) |
Investigations | 518 | 0.36 (0.33–0.4) | 0.38 (562.57) | 0.38 (0.35) | -1.4 (-3.07) |
Respiratory, Thoracic And Mediastinal Disorders | 514 | 0.47 (0.43–0.51) | 0.48 (304.48) | 0.48 (0.45) | -1.06 (-2.73) |
Vascular Disorders | 316 | 0.65 (0.58–0.73) | 0.66 (58.57) | 0.66 (0.6) | -0.61 (-2.28) |
Renal And Urinary Disorders | 245 | 0.58 (0.51–0.66) | 0.59 (71.77) | 0.59 (0.53) | -0.76 (-2.43) |
Metabolism And Nutrition Disorders | 240 | 0.49 (0.43–0.56) | 0.5 (124.46) | 0.5 (0.45) | -1.01 (-2.67) |
Eye Disorders | 224 | 0.49 (0.43–0.56) | 0.5 (115.8) | 0.5 (0.45) | -1.01 (-2.67) |
Social Circumstances | 177 | 1.85 (1.6–2.15) | 1.85 (68.89) | 1.85 (68.89) | 0.88 (-0.78) |
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | 149 | 0.24 (0.2–0.28) | 0.25 (354.76) | 0.25 (0.21) | -2.02 (-3.69) |
Hepatobiliary Disorders | 74 | 0.36 (0.29–0.46) | 0.37 (81.86) | 0.37 (0.3) | -1.45 (-3.11) |
Immune System Disorders | 73 | 0.29 (0.23–0.36) | 0.29 (127.7) | 0.29 (0.24) | -1.78 (-3.45) |
Blood And Lymphatic System Disorders | 66 | 0.17 (0.13–0.22) | 0.17 (262.73) | 0.17 (0.14) | -2.52 (-4.19) |
Reproductive System And Breast Disorders | 63 | 0.34 (0.26–0.43) | 0.34 (81.43) | 0.34 (0.28) | -1.56 (-3.22) |
Ear And Labyrinth Disorders | 57 | 0.59 (0.45–0.76) | 0.59 (16.54) | 0.59 (0.47) | -0.77 (-2.43) |
Pregnancy, Puerperium And Perinatal Conditions | 17 | 0.18 (0.11–0.28) | 0.18 (64.97) | 0.18 (0.12) | -2.49 (-4.16) |
Endocrine Disorders | 11 | 0.19 (0.11–0.35) | 0.19 (37.28) | 0.19 (0.12) | -2.37 (-4.04) |
Congenital, Familial And Genetic Disorders | 5 | 0.07 (0.03–0.17) | 0.07 (59.23) | 0.07 (0.03) | -3.78 (-5.45) |